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NCT Number: NCT04698304

The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions

Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.

The TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

According to the TASC II guidelines, TASC D lesions was recommended for primary endovascular revascularization, TASC C lesions for surgical revascularization in patients with appropriate perioperative risk and available conduit. However, Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.

Despite The shift of Endovascular- first strategy has been documented in recent literature. There still lack evidence to support either approach have a significant advantage over the other. And TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years old
  • Patients with Rutherford classification range from 3 to 6
  • If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study
  • The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle
  • The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion
  • If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
  • For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery
  • Informed consent signed by patients

Exclusion criteria

  • Patients who are unwilling or refuse to sign the informed consent form
  • Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism
  • Patients with thromboangiitis obliterans
  • Patients with failure of endovascular treatment, and transferred to bypass surgery
  • Patients who underwent surgical atherectomy for common femoral artery occlusive lesions
  • Patients with known allergy to heparin, low molecular weight heparin and contrast agents
  • Patients who have been enrolled in other clinical trials in the past 3 months
  • Women during pregnancy and lactation
  • Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (< 3 years), such as tumors, severe liver disease, cardiac insufficiency

Treatment and study plan

endovascular treatment

Procedure

All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent.

Primary outcomes

  1. Technical success rate

    Time frame: 7 days

    Technical success refers to 1. Establishment of continuous blood flow, no early occlusion, acute thrombosis or reintervention driven by target lesion within 7 days after operation

  2. Incidence of major adverse events

    Time frame: 36 months

    major adverse events

  3. Target vessel patency rate evaluated by postoperative ultrasound

    Time frame: 36 months

    Target vessel patency rate

  4. Clinical-driven Target lesion reintervention rate

    Time frame: 36 months

    Target lesion reintervention rate

Secondary outcomes

  1. Clinical-driven Target lesion reintervention rate

    Time frame: 24 months

    Target lesion reintervention rate

  2. Direct medical expenses (3-year cumulative hospitalization expenses and endovascular expenses related to target lesions)

    Time frame: 36 months

    Direct medical expenses

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine
  • First Affiliated Hospital of Zhejiang University
  • First People's Hospital of Hangzhou
  • Huashan Hospital
  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Qingdao Haici Hospital
  • Second Affiliated Hospital of Suzhou University
  • Shanghai Zhongshan Hospital
  • Xiamen Cardiovascular Hospital, Xiamen University
  • Xuanwu Hospital, Beijing

Registry information

Official study title

Physician-initiated, Prospective, Multi-center,Observational Study: The Efficacy of Endovascular Treatment in Femoropopliteal Occlusive Disease (FPOD) With TransAtlantic InterSociety Consensus (TASC) C and D Lesions

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 6, 2021
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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